Bionovo initiates enrollment in Menerba Phase 1 clinical trial for menopausal hot flushes

Mar 28 2011

Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that enrollment has started for the Phase 1 clinical trial testing the safety of two doses of Menerba in postmenopausal women for the treatment of menopausal hot flushes (study # MF101-008), also known as "menopausal hot flashes."

This Phase 1, open-label, randomized, clinical trial of Menerba will be conducted at three clinical sites in Northern California. Forty postmenopausal women between the ages of 40 and 65 years will be randomized to one of two doses of Menerba and treated for 28 days. The primary goal of this study is to assess the safety of two doses of MF101 after 4 weeks of treatment. Dr. Wulf Utian will serve as the Principal Investigator for this study.

"We are pleased to announce that we are initiating the Phase 1 tolerability clinical trial. We are confident that the trial will proceed quickly and successfully. We are diligently executing on all our milestones, clinical and non-clinical activities, in 2011," commented Dr. Isaac Cohen, Chairman and Chief Executive Officer of Bionovo, Inc.

"This Phase 1 clinical trial is testing two doses of Menerba that are higher than the already proven efficacious dose evaluated in our Phase 2 trial, which showed efficacy equivalent to recently approved low dose menopausal hormone therapy (MHT). We are escalating the dose of Menerba to reach similar efficacy as the high doses of MHT. Our goal is to define a full therapeutic window that matches or improves on currently approved MHT drugs," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.